Clinical trials: Serious Bacterial Infection
Gram-negative Bacterial Infections
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Trial name
- NCT05639647
- Testing
- ATM-AVI, BAT
- Where
- 23 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Febrile Illness Acute, Meningitis, Bacterial
Febrile Infants Swedish Study
Approximately one million febrile infants aged ≤60 days present annually to pediatric emergency departments (PEDs) in Europe and the United States.
- Conditions
- Febrile Illness Acute, Meningitis, Bacterial, Urinary Tract Infection (Diagnosis), Invasive Bacterial Infection
- Trial name
- FISS (NCT07134751)
- Where
- 11 sites in Sweden
- Volunteers
- 2,000 people
- Sponsor
- Region Skane
Primary Immunodeficiency (PID)
Subcutaneous Ig NextGen 16% in PID Patients
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP.
- Trial name
- NCT00391131
- Testing
- IgNextGen 16%
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- CSL Limited
Febrile Shivering, Severe Bacterial Infection
Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection
Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial Infection (SBI). Research supporting this assumption is scant.
- Trial name
- NCT02760745
- Testing
- Ancillary tests
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Assaf-Harofeh Medical Center
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Newborn; Infection, Newborn Sepsis
New Protocol for Febrile Neonate Management
The objective of present study was to evaluate clinical and laboratory characteristics of febrile neonate and describe the incidence of SBI in febrile neonates.
- Trial name
- NCT03183531
- Testing
- C reactive protein
- Where
- Turkey (Türkiye)
- Volunteers
- 328 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Invasive Fungal Infections
Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections
The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment…
- Trial name
- NCT06433128
- Testing
- Fosmanogepix solution for infusion, Fosmanogepix 400 mg tablets
- Sponsor
- Basilea Pharmaceutica
Opioid Use Disorder, Serious Bacterial Infections
Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections.
- Trial name
- NCT05817825
- Testing
- Smart IOP Intervention, Peer Recovery Coach
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Fever, Bacterial Infection
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months
The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants. 2200 febrile infants aged less than 3 months will prospectively be included.
- Trial name
- PRONOUR (NCT00800488)
- Where
- France
- Volunteers
- 2,209 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cancer
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell…
- Trial name
- NCT00045292
- Testing
- acyclovir, acyclovir sodium, valacyclovir
- Where
- 6 sites in United States
- Sponsor
- Fred Hutchinson Cancer Center
Infective Endocarditis, Cardiac Device Infection
Oritavancin for Treatment of Serious Cardiac Infections
Cardiac infections, including infective endocarditis and cardiovascular implantable electronic device infections, are associated with substantial morbidity and mortality and are commonly caused by gram-positive bacteria.
- Conditions
- Infective Endocarditis, Cardiac Device Infection, Gram-positive Bacterial Infections
- Trial name
- OSCAR (NCT07550595)
- Testing
- Oritavancin
- Where
- 3 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Kirby Institute
Bacteremia, Healthcare-associated Pneumonia
Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria
Background and rationale: Antimicrobial resistance is a global public health threat. An increasing number of Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics including carbapenems.
- Conditions
- Bacteremia, Healthcare-associated Pneumonia, Ventilator-associated Pneumonia
- Trial name
- XDR-GNB (NCT02134106)
- Testing
- Polymyxin B, Polymyxin B + Doripenem
- Where
- 2 sites in Singapore
- Sponsor
- Tan Tock Seng Hospital
Fever Without Source
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge.
- Trial name
- NCT02179398
- Testing
- Allocation to the Lab-score group, Allocation to the control group
- Where
- Switzerland
- Volunteers
- 278 people
- Sponsor
- University Hospital, Geneva
Bacterial Infections, Pneumonia, Pneumocystis Carinii
A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children.
- Conditions
- Bacterial Infections, Pneumonia, Pneumocystis Carinii, HIV Infections
- Trial name
- NCT00000811
- Testing
- Azithromycin, Atovaquone, Sulfamethoxazole-Trimethoprim
- Where
- 75 sites in United States, Puerto Rico
- Volunteers
- 690 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Candidiasis, Mycoses
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal…
- Conditions
- Candidiasis, Mycoses, HIV Infections
- Trial name
- NCT00002038
- Testing
- Fluconazole
- Where
- United States
- Sponsor
- Pfizer
Candidiasis
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients
- Trial name
- NCT00163111
- Testing
- VFEND® I.V., Oral, Conventional amphotericin B, Diflucan IV, oral
- Volunteers
- 412 people
- Sponsor
- Pfizer
Immunodeficiencies, Primary Immunodeficiencies (PID)
V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency…
- Conditions
- Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia
- Trial name
- VIP (NCT06954441)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Infection, Skin and Subcutaneous Tissue Bacterial Infections
Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections
Military service members and the U.S. veteran population face a growing and serious health threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling pipe-line of sufficiently potent antibiotics.
- Conditions
- Infection, Skin and Subcutaneous Tissue Bacterial Infections, Healthcare-associated Infection, Infection Due to Resistant Bacteria
- Trial name
- RAMPED (NCT02060513)
- Where
- 3 sites in United States
- Volunteers
- 2,298 people
- Sponsor
- Connie Price
Bacterial Infections
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial…
- Trial name
- TANGOKIDS (NCT02687906)
- Testing
- Vabomere
- Where
- 9 sites in United States
- Volunteers
- 39 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Gonorrhea, Meningococcal Disease
Immunisation for Adolescents Against Serious Communicable Diseases (B Part of it NT)
This study aims to implement a targeted 4CMenB immunisation program in young people aged 14-19 years in the Northern Territory (NT).
- Trial name
- NCT04398849
- Testing
- Licenced 4CMenB Vaccine
- Where
- Australia
- Volunteers
- 7,100 people, healthy volunteers welcome
- Sponsor
- University of Adelaide